Date: 2015-10-13
Type of information: Development agreement
Compound: Elelyso™ (taliglucerase alfa)
Company: Protalix BioTherapeutics (Israel) Pfizer (USA - NY)
Therapeutic area: Rare diseases
Type agreement: development clinical research commercialisation
Action mechanism: enzyme replacement therapy
Disease: Gaucher disease
Details: * On December 6, 2012, Protalix BioTherapeutics has entered into a clinical development agreement with Pfizer under which Protalix will continue to manage, administer and sponsor current, ongoing clinical trials relating to Elelyso™ (taliglucerase alfa), an enzyme replacement therapy for the treatment of Gaucher disease. Protalix is currently sponsoring adult and pediatric extension studies of Elelyso™. New clinical trials for Elelyso™ will be conducted and sponsored by Pfizer. This agreement helps to maintain the continuity of the ongoing clinical trials for Gaucher patients and physicians and reinforces the companies\'mutual commitment to the Gaucher community.
On November 30, 2009, Pfizer and Protalix entered into an agreement to develop and commercialize taliglucerase alfa. Under the terms of the agreement, Pfizer received exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while Protalix retained the exclusive commercialization rights in Israel.
Financial terms: Under the terms of the agreement, Protalix is eligible to receive a milestone payment of $8.3 million upon the achievement of certain near-term clinical development milestones.
Latest news: * On October 13, 2015, Protalix BioTherapeutics announced that the Company sold its share in the collaboration agreement for Elelyso™ to its commercialization partner, Pfizer. Under the initial collaboration agreement, Pfizer and the Company shared revenues and expenses for the development and commercialization of Elelyso™ on a 60%/40% basis globally, excluding Israel and Brazil. As amended, Pfizer is responsible for 100% of expenses, and entitled to all of the revenues, globally for Elelyso™, excluding Brazil, where the Company will be responsible for all expenses and retain all revenues. Pursuant to the amended collaboration agreement, the Company will receive $36 Million in cash from Pfizer for the Company's share in the collaboration agreement and the Israeli territory, while Pfizer will transfer to Protalix full commercialization rights in Brazil thereby eliminating annual payments of up to $12.5 Million to which Pfizer was entitled. In addition to the $36 Million cash payment, pursuant to a stock purchase agreement, Pfizer agreed to make a $10 Million investment in exchange for 5,649,079 shares of the Company's common stock subject to certain other terms referenced under the stock purchase agreement.
